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InfectionNCT00363220

Community - Associated Extended-spectrum Beta-lactamases (ESBL)

An observational study of Infection and E Coli Infections, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. Read more about this study

Who is it for?
Any age
How many people
100 participants
Where
1 siteUnited States
Study dates
Aug 2006to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: ESBL infections

Who may be able to join

  • All patients with E. coli, Klebsiella species, and Proteus species infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as:
  • Isolation of the organism two or more days after admission for hospitalization OR
  • History of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date OR
  • The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture OR
  • Previous isolation of an antibiotic resistant organism.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies a urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community. Therefore, the aims of this study are to:

  1. Review whether extended-spectrum beta-lactamase (ESBL)-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated, or community-associated.
  2. Investigate the prevalence of ESBL-positive E. coli in foodstuffs (beef, poultry, turkey, and pork), as a potential source for ESBL producers in the community.
  3. Compare the clonal relationship of the genome and resistance plasmids carried by the ESBL-producing isolates (healthcare-associated, community-associated, and of animal origin) and study the associations of ESBL-mediated resistance with resistance to other classes of antimicrobials.
Read the detailed description

The following variables will be followed: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU, etc.), prior hospitalization or nursing home admission, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, and prior positive microbiologic cultures. All sites are collecting the following information that was collected as part of the patient's clinical treatment. The following variables will be collected at all sites: time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once the organism is identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history. We will collect information prospectively for one year. The bacteria in the patient's cultures will be subcultured (after the diagnosis has been obtained since the microbiology lab would otherwise destroy the culture) and provided to the honest broker who will de-identify the specimen and link it to the medical information collected (which will also be de-identified by the honest broker). The following evaluation will be performed on these samples. The minimal inhibitory concentration of the antibiotic used in treatment will be performed by the E-Test method (AB Biodisk, Solna, Sweden). Specific mechanisms of antimicrobial resistance will be studied with emphasis on the presence of beta-lactamases produced by the bacteria. This evaluation will be performed by analytical isoelectric focusing techniques as well as PCR and gene sequencing analysis to determine genes encoding beta-lactamases. Biologic samples will be under the control of the principal investigator of this research project. All samples provided to the investigators are de-identified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time will the research investigators have access to any patient identifiers. Medical record information and bacteria samples from facilities outside of UPMC will be provided to the PI de-identified. At no time will anyone on the research team have access to patient identifiers. All information and bacteria are collected as part of the patient's clinical treatment.

Keywords
Infection, E coli, Klebsiella, ESBL
Medical subject headings
Infections, Escherichia coli Infections, Klebsiella Infections, Proteus Infections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363220
Sponsor's protocol ID
IRB# 0607059
Other IDs
physician own funding
Status last verified
Dec 2015
First submitted
10 Aug 2006
Last updated
17 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Infection and E Coli Infections, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.

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